The Recall Desk
HighFDA (Devices)·Z-1517-2022·Announced 2022-08-24

Sterile Surgical Pads and Wound Care Kits Recalled Due to Structural Failure

ASO LLC is recalling 274,458 retail packages of three wound care products that fall apart during handling after removal from packaging, compromising their sterility and usability.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a structural defect in FDA Class II sterile wound care products where the product fails during normal handling. Although no illnesses or injuries have been reported, the defect creates a risk of harm by potentially compromising sterility during wound care use, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ASO LLC is recalling three wound care products distributed nationwide and in Canada: CVS Health Sterile Surgical Pads (12 pads, 5 in. x 9 in., ASO Item No. 781083), CVS Health 30 Piece Wound Care Kit for Large Size Wounds (ASO Item No. 781240), and Equate First Aid Kit with 120 items including a sterile trauma pad (ASO Item No. 192636). A total of 274,458 retail packages have been distributed.

The products fall apart during handling after removal from their primary packaging. This structural failure compromises the integrity and sterility of the wound care materials, potentially rendering them unsuitable for safe use on open wounds.

The recalled items were distributed nationwide in Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia, as well as in Canada. Specific lot numbers for each product variant are available from the FDA for identification purposes.

Consumers who have purchased these products should discontinue use and contact their retailer or the manufacturer for a refund or replacement.

The recalled product

Product
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containin
Manufacturer
ASO LLC
Category
Medical Device — Wound Care
Hazard
  • product-disintegration
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item 781083: Lot numbers 2384-20201116
  • 2384-20201123
  • 2384-20201212
  • 2384-20201226
  • 2384-20210111
  • 2384-20210120
  • 2384-20210306
  • 2384-20210327
  • 2384-20210329
  • 2384-20210411
  • 2384-20210522
  • 2384-20210528
  • 2384-20210604
  • 2384-20210610
  • 2384-20210615
  • 2384-20210619
  • UPC 050428310229
  • UDI: 050428310229. Item 781240: Lot numbers 2384-20201109
  • 2384-20201214
  • 2384-20201220

Distribution

Distributed nationwide across the United States.

Related recalls

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